Edwards Touts ‘Excellent’ Real-World Outcomes for Sapien 3 Ultra Resilia TAVR

Edwards Lifesciences revealed one-year data that highlighted the performance of its Sapien 3 Ultra Resilia valve. This data was presented at PCR London Valves 2024 and simultaneously published in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

The data was taken from over 9,000 propensity-matched patients in the STS/ACC TVT Registry. Analysis showed those who received the newest-gen Sapien 3 Ultra Resilia valve experienced “outstanding” one-year outcomes, which continuously surpassed recipients of the earlier generation Sapien 3 and Sapien 3 Ultra valves.

Patients who were implanted with Sapien 3 Ultra Resilia had “extremely low mortality, low rates of reintervention, larger effective orifice areas, lower echo-derived gradients across all valve sizes and no paravalvular leak in 84.4% of cases.”

“These strong, real-world data continue to demonstrate that patients treated with a Sapien valve experience excellent outcomes with rapid recovery and improved quality of life,” said Larry Wood, Edwards’ corporate VP and group president, transcatheter aortic valve replacement and surgical structural heart. “These data add to the immense body of evidence with multiple years of follow up on the Edwards Sapien valve platform and more than 10 years of clinical experience with the RESILIA tissue.”

Patients in the Sapien 3 Ultra Resilia cohort had an average STS score of 3.6 and average age of 77. They showed a “clinically significant” average 31-point increase in KCCQ score and one-day length of hospital stay, with 93% discharged to their homes.

“This is the first large-population study that showed the latest generation SAPIEN 3 Ultra RESILIA valve results in improved 1-year survival after TAVR versus prior generation valves, given it reduces mild or greater paravalvular leak,” said Gilbert Tang, MD, MSc, MBA, Surgical and Academic Director of the Structural Heart Program for the Mount Sinai Health System and Professor and Vice-Chair of Innovation in Cardiovascular Surgery at the Icahn School of Medicine at Mount Sinai. “This finding particularly affected low surgical risk patients, where the impact would matter more because of their longer life expectancies.”

Edwards’ Sapien 3 Ultra Resilia valve launched in the U.S. in September 2022. The valve subsequently rolled out in Europe in May of this year.